Practical Implementation of the Requirements of the SPC Waiver Regulation
Regulation (EU) 2019/933, amending the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (hereinafter referred to as the Regulation) was published in the Official Journal of the European Union on 11th June 2019 and thus came into effect on 1st July 2019. The amended Regulation establishes the so-called “SPC waiver”, that excludes…